Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section

About this trial

Last updated 2 years ago

Study ID

MD-147-2021

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

20 to 40 Years

Female

Trial Timing

Ended 2 years ago

What is this trial about?

The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done. Then, the patients will be divided into 4 groups, receiving Oxytocin only (Group 1), Oxytocin + Tranexamic acid (Group 2), Oxytocin and Misoprostol (Group 3) or Oxytocin and Carbetocin (Group 4) followed by collection of necessary data.

What are the participation requirements?

Inclusion Criteria

* 2. Pregnant women candidate for LSCS. 3. Age: 20-40 years old. 4. Full term pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).

5. Singleton pregnancies. 6. One or more of the following criteria to be considered as high-risk case for PPH (RCOG, 2016):

1. Maternal Anemia (hemoglobin < 10 g%).

2. Known placenta previa.

3. Proven or suspected case of placental abruption.

4. Preeclampsia or gestational hypertension.

5. Polyhydramnios (DVP > 8cm).

6. Macrosomia (> 4 Kg)

7. Previous history of uterine atony or postpartum hemorrhage).

8. Prolonged labour (>12 hours).

7. CS under spinal anesthesia.

Exclusion Criteria

* 1. Fetal death (IUFD). 2. Fetal anomalies. 3. IUGR (Estimated fetal weight below the 5th centile) 4. Women presenting with an obstetric emergency necessitating immediate surgery (Cord prolapse, severe antepartum hemorrhage, severe fetal distress etc.) 5. More than 2 previous CS procedures. 6. Prolonged procedure (more than 2 hours from skin incision to skin closure). 7. History of prostaglandin, Tranexamic acid or carbetocin allergy. 8. Multifetal pregnancies. 9. Abnormally invasive placenta. 10. Known deep venous thrombosis